TheArtOfService
Cross-Framework Mapping

NIST SP 800-66vsISO 13485

See exactly how NIST SP 800-66 controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.

19
Controls Mapped
0
Gaps Found
50%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

NIST SP 800-66 maps to ISO 13485 with 50% coverage across 4 directly mapped controls. Analysis of 8 NIST SP 800-66 controls identifies 4 compliance gaps — primarily concentrated in Integration with NIST RMF, CSF, OCR Enforcement.

Source: TheArtOfService Knowledge Graph | 8 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 19 of 19 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Security Management Process - Risk Analysis and Risk Management(1 mappings)

NISTSP66-1Security Management Process: Risk Analysis and Risk Management for ePHI
→ISO13485-06Security management process and risk analysis

Workforce Security + Access + Training(5 mappings)

NISTSP66-2Workforce Security, Information Access Management, and Awareness Training5 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-07Workforce security and clearance procedures
→ISO13485-08Information access management
→ISO13485-09Security awareness and training program
→ISO13485-17Facility access controls

Physical Safeguards(3 mappings)

NISTSP66-5Physical Safeguards: Facility Access, Workstation Use and Security, Device and Media Controls3 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-08Information access management
→ISO13485-17Facility access controls

Technical Safeguards(10 mappings)

NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication10 targets
→6.4Logging and Monitoring
→ISO13485-01ePHI access controls and authorization
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-03Minimum necessary standard enforcement
→ISO13485-04Patient data de-identification procedures
→ISO13485-05Audit trail for ePHI access
→ISO13485-08Information access management
→ISO13485-12Unique user identification and authentication
→ISO13485-16Transmission security and encryption
→ISO13485-17Facility access controls

Related Comparisons

Other NIST SP 800-66 comparisons

NIST SP 800-66 vs Turkey KVKK4 mappingsNIST SP 800-66 vs Privacy Act 1988 (Australia)4 mappingsNIST SP 800-66 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements4 mappingsNIST SP 800-66 vs ISO 277994 mappingsNIST SP 800-66 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)4 mappingsNIST SP 800-66 vs BSI IT-Grundschutz4 mappingsNIST SP 800-66 vs Annex 11 to EU GMP - Computerised Systems4 mappingsNIST SP 800-66 vs ISO 270194 mappings

Other ISO 13485 comparisons

MDS2 (Medical Device) vs ISO 1348513 mappingsMARS-E vs ISO 1348513 mappingsISO 27799 vs ISO 1348513 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO 1348512 mappingsNIST Privacy Framework vs ISO 1348512 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs ISO 1348512 mappingsOman National Cybersecurity Framework vs ISO 1348511 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs ISO 1348511 mappings

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Popular framework comparisons

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What are the key differences between NIST SP 800-66 and ISO 13485?

NIST SP 800-66 has 8 controls across its framework, while ISO 13485 covers 29 controls. Direct mapping analysis identifies 4 overlapping controls (50% coverage). The frameworks diverge most significantly in Integration with NIST RMF, CSF, OCR Enforcement, where 1 NIST SP 800-66 controls have no direct ISO 13485 equivalent.

How many controls map between NIST SP 800-66 and ISO 13485?

Of 8 total NIST SP 800-66 controls, 4 map directly to ISO 13485 controls — representing 50% coverage. The remaining 4 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping NIST SP 800-66 to ISO 13485?

4 NIST SP 800-66 controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in Integration with NIST RMF, CSF, OCR Enforcement with 1 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between NIST SP 800-66 and ISO 13485?

The domain with the highest gap count is Integration with NIST RMF, CSF, OCR Enforcement (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.